RBL: Retrospective Analysis of Rituximab-containing Immunochemotherapy for Burkitt's or Burkitt-like Lymphoma in Adults
Study Details
Study Description
Brief Summary
This retrospective study is aimed at evaluating the safety and efficacy of rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Inclusion criteria
-
pathologically confirmed BL or BL-U by World Health Organization 2008 criteria
-
age >20 yrs
-
received rituximab+chemotherapy as first-line treatment
-
with measurable or evaluable lesion
-
with complete set of clinical and laboratory data for the analysis
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Burkitt's Lymphoma should be diagnosed pathologically by WHO 2008 criteria |
Other: No intervention (observational study)
|
Outcome Measures
Primary Outcome Measures
- Event-free survival [one year]
Event-free survival is measured from the time from treatment initiation to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death)
Secondary Outcome Measures
- complete response rate [1-year]
treatment response will be evaluated according to the Revised criteria for malignant lymphoma (Journal of Clinical Oncology 25:579-586)
- overall survival [1-year]
Overall survival is defined as the time from treatment initiation until death as a result of any cause
- Grade 4 hematologic toxicities [one year]
toxicities will be graded according to Common Toxicity Criteria for Adverse Events (CTCAE) V.4.0. Hematologic toxicities planned to evaluated were; anemia (by hemoglobin), absolute neutrophil count, and platelet count
Eligibility Criteria
Criteria
Inclusion Criteria:
-
pathologically confirmed Burkitt's lymphoma (BL) or High grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL (BL-U) by WHO 2008 criteria
-
age >20 yrs
-
received rituximab+chemotherapy as first-line treatment
-
with measurable or evaluable lesion
Exclusion Criteria:
- patients with BL or BL-U previously treated with rituximab
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | 405-760 |
Sponsors and Collaborators
- Gachon University Gil Medical Center
Investigators
- Study Director: Suk Jin Kim, MD, PhD, Samsung Medical Center, Seoul, Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CISL-1203